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After reporting new clinical trial data, Ionis Pharmaceuticals and AstraZeneca plan to submit an NDA for eplontersen for treating ...[ Price : $8.95]
Four drug industry stakeholders ask FDA to clarify elements in a draft guidance on interoperable exchange of information under the...[ Price : $8.95]
Pacira BioSciences plans to submit a supplemental NDA early next year to broaden the label on its post-surgical pain drug Exparel ...[ Price : $8.95]
CBER announces a 10/5 Webinar entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission.[ Price : $8.95]
FDA lifts its clinical hold on Sareptas investigational Duchenne muscular dystrophy drug SRP-5051.[ Price : $8.95]
FDA warns St. Louis, MO-based Leaf of Life that its Web site takes orders for dietary supplements that are legally considered to b...[ Price : $8.95]
FDA approves expanded labeling for Boston Scientifics Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual a...[ Price : $8.95]
CDER scientists are working to improve the bioavailability of generic drugs that do not dissolve well in water.